ifc fcs consultant guide v4
TRANSCRIPT
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CONTENTS
(i). Introduction 3
1. Prerequisite Programs1.1. The Construction and Layout of Buildings 61.2. The Layout of Premises and the Workspace 71.3. Utilities: Air, Water, Energy 81.4. Waste Management 91.5. Equipment Suitability, Cleaning, and Maintenance 101.6. Management of Purchased Materials 111.7. Measures for the Prevention of Cross-Contamination 121.8. Cleaning and Sanitizing 131.9. Pest Control 141.10. Personal Hygiene and Employee Facilities 151.11. Rework 161.12. Product Withdrawal and Recall 171.13. Warehousing 181.14. Product Information and Consumer Awareness 191.15. Food Defence, Bio-vigilance, and Bioterrorism 201.16. Food Fraud 21
2. Food Safety Management System 2.1. Context of the Organization 232.2. Needs and Expectations of Interested Parties 242.3. Scope of the Food Safety Management System 252.4. Food Safety Management System 262.5. Food Safety Policy 272.6. Organizational Role, Responsibility, and Authority 282.7. Risks and Opportunities 292.8. Food Safety Objectives 302.9. Change Management 312.10. Competence 322.11. Infrastructure 332.12. Work Environment 342.13. Communication 352.14. Documented Information 362.15. Traceability 372.16. Emergency Preparedness and Response 382.17. Control of Monitoring and Measurement 392.18. Nonconformity and Corrective Actions 402.19. Withdrawal and Recall 412.20. Performance Evaluation 422.21. Internal Audit 432.22. Management Review Meeting 44
3. Hazard Analysis Critical Control Points 3.1. Development of the HACCP Plan 463.2. HACCP System Requirements 47
Annex 1: Tips for Virtual Training and Coaching 49Annex 2: Scheduling and Project Tracking 51
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This document provides guidelines for food safety specialists and consultants on coaching client food safety teams. The main objective of the document is to ensure a consistent approach across all food safety projects. The guidelines are not intended to replace engagement with experienced specialists or consultants during the project.
Assess, train, coach, and reassess is the approach of the International Finance Corporation (IFC) in providing food safety advisory services. To ensure that all specialists and consultants have the same understanding, each activity is clearly defi ned. Brief explanations are as follows:• Assessment involves the use of a set of criteria or a food safety standard, making a judgment on which of the requirements are fulfi lled and which are not yet fulfi lled. An initial food safety assessment report usually covers any gaps identifi ed in the eff ort to meet the food safety standard and a relevant implementation plan.• Training involves an established curriculum that is delivered on a one-to-many basis. The focus is on building skills or individual behavioral change.• Coaching involves a personalized plan that has been devised by the coach and the protégée and that is delivered on a one-to-one or one- to-few basis. While the focus may be on building skills, it is more often viewed as an opportunity for strategizing or for the coach to serve as a thinking partner.
Because the competency and capability of each client food safety team and the complexity of each process vary, no single solution should be considered better for coaching every team. This document is best used as a compass while walking the client through the journey during implementation. It is not necessary to follow every step mentioned under every heading. The topics in this document have been selected to conform to the Global Food Safety Initiative’s (GFSI) Global Markets Program (GMaP), the International Organization for Standardization (ISO) 22000 food safety management standard, and the ISO 22002-1 technical specifi cation (TS). It is thus the consultant’s responsibility to understand the client’s needs, make necessary adjustments during implementation by, for example, providing coaching on additional requirements, achieve the targeted certifi cation, and meet applicable local norms, exporting country regulations, and the requirements of customers.
The food safety specialists and consultants should coach the client’s food safety team according to these guidelines, explain the reasons behind each procedure, and clarify all documented information. A good understanding of the why will help the team not only establish a viable food safety management system (FSMS), but also maintain and update the system as required. Every IFC Food Safety Advisory Project begins with an initial assessment and an implementation plan, which may then be followed by a project tracker. A template for tracking the progress of a project and for checking if all items are addressed is provided in annex 1. These guidelines can be used in face-to-face or virtual coaching. There are some diff erences between in-person and virtual deliveries. Appropriate tips on virtual training and coaching are provided in annex 2 to assist the consultant in delivering the services eff ectively.
In general, there are three phases in coaching a client food safety team, as follows: (1) use the initial assessment as a guide and analyze the current situation and condition underlying each element of the prerequisite program (PRP) or FSMS, (2) adopt a step-by-step approach to the implementation of specifi c elements of the PRP or FSMS and to additional requirements, and (3) maintain and update the FSMS that has been implemented by the food safety team. These three phases are explained under each topic by relying on a color-coded format, as follows:
• The title of each page may refer to a PRP, an element of the FSMS, or a key item in the hazard analysis critical control point (HACCP).• The bar above describes the phases: assessment and implementation, system requirements, and maintenance and update. The phases are also color- coded.• A description in bold or a step in dark blue are the intermediate level requirements of the GMaP; the reader may also refer to the clause number.• The numbers in the right columns refer to the clauses of the GMaP or the ISO 22000 and ISO/TS 22002-1 requirements.• Food fraud is also covered. It has become more important to protect food products from contamination or adulteration that is aimed at causing public health problems or business losses.
INTRODUCTION
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INTRODUCTIONIn this phase, the consultant gets to know the details of the specific food business more clearly by walking the factory and having conversations with management and employees. The consultant’s role is to identify gaps between the current conditions and the requirements of the standard. The output of earlier steps feeds into the next steps.
GENERAL GUIDELINES FOR COACHING CLIENT FOOD SAFETY TEAMSM
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n Baseline study or gap assessment - walk the factory, collect data, interview management and employees, and so on.
Define specifications, criteria, roles, and responsibilities, and so on. Conduct risk assessments as needed.
Develop and document procedures, programs, plans, policies, schedules, standard operating procedures (SOPs), and forms
Implement procedures, programs, and plans and record activities and results
Training of respective department (or) all staff
Monitoring, recording, and evaluation
Monthly trends and corrective action and preventive actions (CAPA), if needed
Report trends and significant changes at the management review meeting (MRM)
Periodic review of the PRP
Description GMaP ISO
Implementation requirements Ref clause Ref clause
Record requirement
System requirementsGMaPClause
no.
ISO 22000Clause
no.
...
4.1
This shows what the food safety team needs to do to sustain the FSMS implemented at their site. Client involvement beginning at the assessment phase is key to sustaining the system after the consultant has completed the implementation and departed from the client’s team.
The requirements of the GMaP and ISO22000 or ISO/TS 22002-1: The clauses can be seen in the columns or separately in the color-coded format. The consultant needs to ensure that the client’s FSMS meets the targeted food safety certification requirements, local and export country regulations, and customer needs. Documented record requirements are shown in italics.
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INTRODUCTION1.1. THE CONSTRUCTION AND LAYOUT OF BUILDINGSM
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n Assess the current situation: the external environment, fences, entrances, roof, building design and layout, employee facilities, external lighting, drainage, wastewater system, surroundings of buildings, external cleaning and maintenance, waste collection areas
Develop – (1) improvement plan (if needed) and (2) external cleaning and maintenance program
Follow up on progress; Implement the external cleaning and maintenance program
Training of respective department (or) all staff
Regular monitoring, cleaning and maintenance, and inspection
Report incidents (if any) at the MRM
Periodic review of the facility environment
Description GMaP ISO
• No source of contamination next to the factory• Complete fence• Clearly defined gates with control of access (for example, a guardhouse)• Solid buildings that are properly designed• No trees or soil next to building• No construction sites in the compound unless properly isolated or barricaded• Sufficient lighting in the compound• Light fixtures to be protected (related PRP Control of Cross-contamination–GMaP: B.B.4
and ISO:10.4)• Food-contact structures: surfaces and materials that come into contact with food are
easy to maintain, clean, and, where appropriate, disinfect• Properly sloped and well-maintained drains• Free of waste and debris in the compound (related PRP Waste Management–GMaP: B.B.8
and ISO:7.1-7.4)
B.B.2 4.14.24.34.36.6
• Changing rooms provided for staff• Sufficient number of toilets provided, operational, accessible, and adequately segregated
from processing and food handling areas• Suitable and sufficient hand-washing facilities provided and accessible• Lunch room facilities provided away from production, packaging, and storage areas• Review of contamination prevention procedures conducted at least annually
B.B.7
Records required- Access control records (vehicles, employees, contractors, visitors)- Site cleaning and maintenance records- Contamination prevention program review record
4.2
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INTRODUCTION1.2. THE LAYOUT OF PREMISES AND THE WORKSPACEM
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n Check the internal environment: walls, floors, ceilings, doors and windows, storage areas, drain points, drains, equipment design and layout; review the locations of high- vs. low-risk zones; review production lines
Define risk zones; develop pathways of materials and people; develop an improvement plan (if any changes are required); develop building cleaning & maintenance program; develop environmental monitoring program (sampling, testing, reporting, trending)
Follow up on progress; implement building cleaning & maintenance program
Training of all staff
Regular monitoring, cleaning and maintenance, and inspection
Report incidents and changes (if any) at the MRM
Periodic review of premises and workspaces
Description GMaP ISO
Related FSMS element 2.11. infrastructure – ISO: 7.1.3.
Proper doors, windows, screens, physical barriers (for example, shoe change bench) or effective proce-dures in place
B.B.4.
Internal layout design is available.Good hygiene and manufacturing practices are followed.
5.1
Internal layout and traffic patterns and routes (raw materials, products, waste, personnel) and entry and exit points are available.
5.2
Suitable materials and design in construction, curved wall-floor junctions, dry or drainable floors, ceil-ings, screened windows, vents are in place.Doors are closed when not in use.
5.3
Hygienic design and appropriate location of equipment. 5.4
Laboratory activities are controlled in designated areas. 5.5
Design and location are assessed; additional assessments are conducted if there are hazards associated with temporary or mobile premises and vending machines.
5.6
Storage areas are identified and marked.All items are placed off the floor by using pallets, and sufficient space is maintained for inspections.Chemical and other hazardous substances are stored in designed storage areas only.Bulk storage procedures are established and followed.
Records required- Assessment records- Temperature, relative humidity records on storage areas
5.7
A documented building maintenance program is established I.B.10
An effective building maintenance program is implemented
Hygiene and clearance procedures for all maintenance activities are in place
Hygiene procedures for maintenance activities are reviewed and their effectiveness has been verified
Suitable materials are used for maintenance and repair
Maintenance records- Building maintenance program review record- Hygiene control records and area clearance records- Review records on hygiene procedures for maintenance activities
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Description GMaP ISO
Control measures implemented to ensure the quality of water and guarantee that steam and ice do not compromise the safety of food products
B.B.6.1 6.16.2
Potable water is physically segregated from non-potable water, and lines are color-coded or labelled; water quality requirements are specified and met
B.B.6 6.2
Ingredient water, cleaning water, product contact air, and room air are monitored through the respective programs; residual chlorine is checked at the point of use
6.1/6.46.2
Water that may come indirectly into contact with products are identified and checked to ensure it meets specified quality and micro requirements
6.2
(Recommendation) potable water pipes should be accessible to disinfection 6.2
Boiler chemicals should include only approved additives, stored separately, and secured 6.3
Filtration, relative humidity and micro requirements are established; controls are in place on air that comes into contact with products
Sufficient ventilation should be provided; correct air flows from high- to low-risk zones, systems are cleanable; periodic inspections are carried out of external filters and air intakes
Quality monitoring and control and correct pressure differentials in room air are maintained
6.4
Compressed air and other gases: construction and maintenance to prevent contamination; food grade; filtered; use of oil-free compressors or food grade oil
Records requiredWater, steam, and ice test records and resultsList of approved chemicalsAir monitoring test records and results, room temperature and relative humidity records, differential pressure records, filter cleaning and replacement recordsCertificate of analysis or test results of compressed air and other gases
6.5
INTRODUCTION1.3. UTILITIES: AIR, WATER, ENERGYM
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n Check existing air and water supply: from source to point of use; product contact air vs. ventilation vs. compressed air; portable vs. technical water supply vs. return lines; treatment (if any); stagnation; differential pressure; flow disturbance; user point treatment, filtration, cleaning; air and water quality monitoring program; check electricity lines and backup energy system
Develop a maintenance program (such as drain water lines, air filter cleaning and replacement); air and water quality monitoring program (sampling, testing, reporting, trending, and review)
Implement quality monitoring program and maintenance program
Training of all staff
Regular monitoring, cleaning and maintenance, and inspection
Report incidents and changes (if any) at the MRM
Periodic review of facility environment
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INTRODUCTION1.4. WASTE MANAGEMENTM
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n Identify waste generation points and temporary storage locations
Define the waste transfer route(s)
Develop storage, transfer and disposal methods based on waste types
Implement a waste management program
Monitoring, recording, and inspection
Training of all staff
Monthly record of CAPA (if any)
Report at the MRM (if necessary)
Periodic review of the waste management system
1.4. WASTE MANAGEMENT
Description GMaP ISO
Identified waste generation points
Waste bins have lids and are color-coded and labeledWaste bins are located in designated areasWaste bins are properly utilized and cleaned
A waste transfer route has been defined (related PRP: Layout of building premises and workplace GMaP: B.B.4, ISO: 5.2), and waste is transferred over this route
The temporary waste collection bin is at least 10 feet from the building and regularly cleaned
Waste disposal by a third party has been organized
A procedure for managing ‘waste containing labels and packaging materials’ has been established
Drains are properly designed (sufficient to handle flow, only to flow from high- to low-hygiene zones, and so on), maintained, and cleaned
Waste disposal record
B.B.8 7.1
7.2
7.3
7.4
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INTRODUCTION1.5. EQUIPMENT SUITABILITY, CLEANING, AND MAINTENANCEM
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n Identify and prepare a list of equipment
Ensure the suitability of construction materials, lubricants, and hygienic design
Prepare preventive maintenance master plans
Identify roles and responsibilities
Identify maintenance methods and tools
Monitoring, recording, and inspection
Training of all staff
Monthly record of CAPA (if any)
Report at the MRM (if necessary)
Periodic review of the waste management system
1.4. WASTE MANAGEMENT
Description GMaP ISO
Documented cleaning procedures (facility, utilities, and equipment) are in place.The effectiveness of cleaning is verified.A cleaning master plan for equipment, including cleaning tools, is available.
Cleaning tools are color-coded and clearly marked.Cleaning chemicals are marked and stored separately.
Personnel who undertake cleaning and disinfection have been trained.
Food contact surfaces are made of suitable materials (can be cleaned and disinfected).Hygienic design requirements f o r equipment have been met.Food contact surfaces are made of suitable materials (impermeable, free of rust and corrosion, fit for temperature and holding conditions).
A preventive maintenance program is in place.Corrective maintenance procedures are available.Temporary vs. permanent repair and the priorities of maintenance requests are identified.Lubricants and heat transfer fluids are food grade.Post-maintenance cleaning, sanitizing, and release; the pre-use inspection of processes and equipment are undertaken.
Records requiredEquipment cleaning and maintenance recordsHygiene control records for maintenance activitiesFood grade certificates for lubricantsPost-maintenance inspection record and verification records; test results (where necessary)
B.B.3.1
B.B.3.2
B.B.3.3
8.5
8.6
8.18.28.38.4
8.6
Training of maintenance and all staff
Cleaning, preventive and corrective maintenance activities
Incident management, CAPA, and change control records
Report at the MRM (if necessary)
Periodic review of maintenance program effectiveness
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INTRODUCTION1.6. MANAGEMENT OF PURCHASED MATERIALSM
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n Assess current purchasing practices and normsMake a list of all existing suppliers of both material and servicesCollect data on receiving criteria for materials and service agreements and contractsReview sampling, testing, and receive and reject processes
Determine appropriate supplier selection processes and develop approved supplier listPlan to improve sampling, testing, and receive and reject processes (if needed) Develop a supplier performance appraisal program
Implement a supplier selection program and conduct performance reviews
Monitoring, recording, and inspection
Training of all staff
Monthly record of CAPA (if any)
Report at the MRM (if necessary)
1.4. WASTE MANAGEMENT
Training of staff involved in purchasing, receiving, and warehousing
Receiving, sampling, and testing are ongoing as specified by procedures
Regular monitoring of supplier performance (at least annually)
Review of supplier performance and update of approved supplier list
Description GMaP ISO
Incoming material requirements: the condition of delivery vehicles is checked; materials are inspected and tested or are covered by certificates of analysis.A documented verification method has been established.Risk assessment and the frequency of inspection are defined.A procedure for handling materials that are out of specification is in place.Accessing, sampling, testing, and release procedures exist for bulk materials (if needed).
I.A.13I.A.14
9.3
A supplier selection process is in place.An approved supplier list is available.Raw material specifications and receiving procedures are available and applied.A procedure for handling materials that are out of specification has been designated.The verification of supplier performance is conducted.
Records requiredIncoming vehicles inspection recordsRaw materials inspection and testing recordsSampling and testing recordsOut of specification handling recordsTest results and release recordsUpdated, approved supplier listSupplier performance review records
9.2
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INTRODUCTION1.7. MEASURES FOR THE PREVENTION OF CROSS-CONTAMINATIONM
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Assess the hazards in each building, zone, and area; review and evaluate if barriers and routes are sufficient for the prevention of cross-contamination
Review the potential of physical, chemical, microbial, and allergen cross-contamination through movement and the use of materials, including tools
Implement contamination control procedures
Develop an improvement plan for segregation and contamination control (if needed)
Monitoring, recording, and inspection
Training of all staff
Monthly record of CAPA (if any)
Report at the MRM (if necessary)
1.4. WASTE MANAGEMENT
Training of all staff
Regular monitoring, cleaning and maintenance, and inspection
Report incidents (if any) at the MRM
Periodic review of contamination control procedures
Description GMaP ISO
The risk of physical, chemical, and microbiological contamination of products is minimizedPhysical barriers are established where needed (see also the PRP Layout of Premises and the Workspace, GMaP: B.B.4, ISO: 5.1)The separation of raw materials from in-process and finished products
Physical contamination control procedures (glass policy, inspection, breakage management, and so on)The management of wooden pallets, tools, rubber seals, and personal protective clothing and equipment
B.B.410.110.4
Zoning map and traffic routes (see also the PRP Layout of Premises and the Workplace, GMaP: B.B.4, ISO: 5.1)A contamination hazard assessment is conducted in each areaThe access to high-risk zones is controlled
10.2
A documented allergen management procedure is in place (related PRP: 1.14. Product Information and Consumer Awareness, GMaP: B.A.2.4; ISO: 1.7)
B.C.2 10.3
Records required
Glass, brittle materials inspection records
Wooden pallet inspection records
Allergen management records (for example, allergen cleaning record)
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INTRODUCTION1.8. CLEANING AND SANITIZINGM
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Monitoring, recording, and inspection
Training of all staff
Monthly record of CAPA (if any)
Report at the MRM (if necessary)
1.4. WASTE MANAGEMENT
Regular cleaning, sanitation, and inspection
Training of all staff
Environmental monitoring trends and CAPA
Report at the MRM
Periodic review of the cleaning and sanitation program
Assess current cleaning practices – Define types of cleaning: dry vs. wet; equipment cleaning in place vs. cleaning out of place
Prepare cleaning and disinfection master plans
Define roles and responsibilities
Develop and implement cleaning methods
Verify cleaning and sanitization program effectiveness
Implement cleaning and sanitization program
Description GMaP ISO
Cleaning and sanitation master plan, including cleaning the cleaning tools, is established.Cleaning in place lines are separated from product lines.Cleaning in place and cleaning out of place plans, including cleaning parameters and criteria to trigger cleaning, have been defined.
B.B.3.1 11.111.4
Cleaning and sanitization verification program is in place.Equipment monitoring plan has been established (critical surfaces).Post-cleaning inspections and pre–start-up inspections are set up.Cleaning verification procedures are in place.
B.B.3.111.111.311.5
Cleaning tools are color-coded and marked.The storage of cleaning tools and cleaning and sanitation chemicals has been providedMethods for cleaning tools are defined.
B.B.3.2 11.2
Trained, qualified people are involved in cleaning and disinfection. B.B.3.3.Records requiredCleaning and sanitation recordsCleaning in place and cleaning out of place recordsCleaning verification recordsCleaning validation recordsTraining recordsTool cleaning recordsCleaning tools and cleaning and sanitation chemical inventory records
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INTRODUCTION1.9. PEST CONTROLM
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Monitoring, recording, and inspection
Training of all staff
Monthly record of CAPA (if any)
Report at the MRM (if necessary)
1.4. WASTE MANAGEMENT
Description GMaP ISO
Pest control procedures are in place, and there is no evidence of pest infestation on siteB.B.5.1 12.1
A pest monitoring program that includes monitoring methods and devices, schedule, trap maps, records, trends, inspections, and actions is available.Pest proofing and other harborage and infestation preventive measures are in place.Regular inspections on the breach of pest proofing and signs of pest infestation are conducted, and the findings lead to rectification.Control procedures, including chemical controls, such as on baits and pesticides, have been established.Eradication is conducted if any infestation occurs, eradication records are maintained.
B.B.5.2
12.212.512.312.412.6
List of approved chemicals, product information, and material safety data sheets are available. B.B.5.3 12.2
An inspection program is undertaken by a trained person at an appropriate frequencyLicensing and legislative requirements on the use of chemicals are met.
B.B.5.4
Records requiredTraining records, licensing for pest controllers and in-house pest control teamPest risk assessment and list of target pests; pest trap layout mapDaily or weekly monitoring records and monthly trendsList of approved chemicals, product information, material safety data sheetsSite inspection records, findings, CAPA, and closure of findings
Recording, trend reporting for the pest monitoring program, recommended actions (if needed)
Training of all staff to ensure awareness and to report pest sightings
Regular site inspections, findings, and follow-up eradication actions
Report at the MRM (if any significant issues) arise
Periodic review of pest management system effectiveness
Assess site situations (process, pest presence, site cleanliness, people’s behavior, and staff capability) and choose one option that is outsourced or in-house
Identify pests at the site Identify pests at the site
Conduct pest risk assessment Conduct pest risk assessment
Assign person in charge of pest control Identify target pests
Get quotation (including service specifications) Assign pest control team and leader
Interview and select suppliers Train staff and acquire licenses
Sign contracts Develop and implement solutions
Outsourced In-house
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INTRODUCTION1.10. PERSONAL HYGIENE AND EMPLOYEE FACILITIESM
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n Assess whether employee facility requirements are fulfilled
Conduct risk assessments on hygiene
Identify gaps and develop hygiene control procedures
Implement procedures
Monitoring, recording, and inspection
Training of all staff
Monthly record of CAPA (if any)
Report at the MRM (if necessary)
1.4. WASTE MANAGEMENT
Training and communication among all staff, contractors, and visitors on health and hygiene requirements
Regular monitoring, inspection, and follow-up actions for violations
Report incidents (if any) at the MRM
Periodic reviews of program effectiveness
Description GMaP ISO
Personal hygiene measures are applied for relevant contractors, visitors, and others.Sufficient dedicated handwashing stations with hands-free features, rest rooms with handwashing and sanitizing facilities, changing facilities, eating and personal food storage areas are available.
B.B.1.1 13.1
13.2
Personal hygiene requirements comply with legal requirements (if applicable). B.B.1.2
Hygiene procedures are communicated to employees, contractors, and visitors.Personnel are informed about how to report cases of Illness or injury.
B.B.1.313.6
A qualified person is assigned to manage health and hygiene controls on individuals.Pre-employment medical examinations and regular checkups on health status are conducted.
B.B.1.413.5
Personal hygiene requirements are communicated through visitor hygiene control forms, visual instructions, briefings, training, and refresher courses.Personal cleanliness is inspected regularly.Procedures for checking and taking action, including retraining, are observed if any improper personal behaviors (smoking, eating, and so on).
B.B.1.5
13.713.8
Employees, contractors, and visitors are informed about requirements and procedures on uniforms and protective clothing.Protective clothing (uniforms, shoes, gloves, and so on) meet hygiene requirements.
B.B.1.613.4
Staff canteens and designated eating areas are located properly. 13.3
Records requiredTraining and communication recordsPosters on handwashing and other hygiene controlsHealth and hygiene checkup records on employeesHygiene controls and personal property control forms that are to be completed before contractors and visitors enter the premisesCopy of local regulations (if applicable)Employee health examination records (pre-employment and regular examinations)
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INTRODUCTION1.11. REWORKM
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Identify points of rework generation
Define labelling requirements for rework
Review storage, transport, expiration, and rework usage guidelines and develop an improvement plan (as needed)
Implement rework procedures
Training of all staff
Training of all staff
Training of all staff
Training of all staff
Training of all staff
1.4. WASTE MANAGEMENT
Training of all staff on awareness of rework handling
Recording generation, storage, and use of rework (ongoing)
Follow-up for inspection findings
Report incidents (if any) at the MRM
Periodic review of the waste management system
Description GMaP ISO
Specifications are available for all product inputs (raw materials, ingredients, additives, packaging materials, rework) and finished products.
B.A.1.1 14.1
Rework procedures with traceability for work in progress, post-treatment, and rework are establishedStorage areas have been assigned for rework.Labeling requirements for rework—label color and detailed information requirements on label (classification, date of generation, reason for rework, designation)—are defined and being implemented.
B.A.2.2 14.2
Recording procedures for the generation, storage, and use of rework are in place. B.A.2.3
Handling procedures for the removal and segregation of packaging materials and contamination controls while rework is being generated from packed products are active.
14.3
Instructions for reuse (acceptable quantity, process steps, methods of addition, and preprocessing if required) are clearly defined and communicated to personnel.
14.3
Records requiredSpecificationsTraining records on rework proceduresRecords of generation, storage, testing, and reuse or rejection of reworkHygiene and packaging materials control records for rework generated from packed products
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1.12. PRODUCT WITHDRAWAL AND RECALLM
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Review if any withdrawal and recall procedures are in place and effective
Develop and refine procedures and the roles and responsibilities of individuals for incidentsManagement Team
Implement revised withdrawal and recall procedure
Verify traceability and test effectiveness by conducting a mock recall
1.4. WASTE MANAGEMENT
Training of staff on withdrawal and recall procedures
Conduct a mock recall annually and maintain a record
Report on the mock recall exercise at the MRM
Periodic review of the effectiveness of the procedure
Description GMaP ISO
Affected products can be withdrawn and recalled.- Related FSMS Element 2.14. Traceability–GMaP: B.A.2, I.A.2; ISO: 8.3- The effectiveness of the traceability system is tested at least annually and the
system is updated- Related FSMS Element 2.19 Withdraw and Recall
Records of incidents are maintained.
B.A.3B.A.2I.A.2I.A.3
Documented incident management system that addresses incident reporting, product withdrawal, and product recall is in place.Products failing to meet required food safety standards can be identified, located, and removed from any point of the supply chain.
I.A.3.3.15.1
Communication plan with designated responsible persons identified to provide information to customers, consumers, and regulatory authorities has been established.A list of key contacts in the event of a recall is available.Mock recall and internal and external incident communication have been tested.
I.A.3.4 15.2
The incident management system is reviewed, tested, and verified at least once a year I.A.3.5
All incidents are recorded; their severity and consumer risks are assessed.If products are withdrawn because of immediate health hazards, the safety of other products produced under the same conditions must be evaluated. The need for public warnings should also be considered.
I.A.3.6 15.2
Records requiredIncident reports(Incident management system) review recordMock recall reports
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1.13. WAREHOUSINGM
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Review warehouse procedures and storage practices (including vehicles)
Develop an implementation plan on good warehousing practices as needed
Implement good warehousing practices
1.4. WASTE MANAGEMENT
Training of warehouse and related staff (dispensing, purchasing sections, and so on)
Regular monitoring, cleaning and maintenance, and inspection of storage areas and vehicles
Report incidents (if any) at the MRM
Periodic review of good warehousing practices
Description GMaP ISO
Facilities for the storage of food and ingredients are adequate. B.B.9.1
Food storage facilities are constructed of materials that can be cleaned and maintained.Separate storage areas for waste materials and chemicals has been established.Separate areas or segregation of nonconforming materials.
B.B.9.2 16.216.2
Appropriate transport is used to transport foods.Warehouse temperature, humidity, and other environmental conditions are controlled.Lower layers are protected (limiting stacking height, using pallets for ventilation, and so on)
B.B.9.3. 16.216.3
Specify first in, first out; first expired, first out. 16.2
A documented product transport procedure is available and effectively implemented. I.B.9.1
A documented transport vehicle procedure is available and effectively implemented.Gasoline- or diesel-powered fork-lifts are not allowed in food ingredient or food product areas.
I.B.9.2 16.2
Documented maintenance and hygiene processes for vehicles and equipment for loading and unloading are available and effectively implemented.Vehicles, conveyors, and containers are to be well-maintained and protect products against damage and contamination.(Where the same vehicle is used for food and nonfood items), cleaning is carried out before use with food items.Dedicated bulk containers are used for food.
I.B.9.316.3
16.3
Records requiredRecords of food storage (with location ID) and transportRecords on material receiving, storage, and useRecords of temperature, humidity, and so on, for storage and food transport (as appropriate)Cleaning records (where necessary)Good warehousing practice review records
19
1.14. PRODUCT INFORMATION AND CONSUMER AWARENESSM
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Req
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Review all labels and revise if necessaryReview the label management process
Develop an improvement plan for meeting labelling requirements and for label and information management
Implement proper checks to ensure labelling requirements are met and label information is well managed
1.4. WASTE MANAGEMENT
Training of relevant staff (production, warehouse, procurement, marketing, and so on)
Regular controls on labelling
Report incidents (if any) at the MRM
Periodic review of labelling requirements
Description GMaP ISO
Clear labeling procedures are in place and ensure continuous identification of products through all stages of production and delivery.- Related FSMS Element 2.14. Traceability–GMaP: B.A.2, I.A.2;
ISO: 8.3- Related PRP 1.13. Warehousing–GMaP: B.A.9; ISO: 16- Related PRP 1.7. Measures for the prevention of cross- contamination- (Allergen Control–GMaP: B.B.4.; ISO: 10.3)
B.A.2.4
Labeling guidelines are available and meet legislative requirements (if any).The information to be communicated with customers or consumers is clearly defined.Information is communicated with customers and consumers though labels and descriptions on contracts.
17
Records requiredBin cards, labels, and so on for raw materials through all stages up to finished productFinished product labels Samples of communication with customers through contracts
20
1.15. FOOD DEFENCE, BIO-VIGILANCE, AND BIOTERRORISMM
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pd
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Req
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Establish a food defence team and define roles and responsibilities
Identify threats in the environment and the process
Perform a threat assessment and critical control point (TACCP) analysis and develop a relevant action plan
Implement action plan
1.4. WASTE MANAGEMENT
Training of food defence team and all staff
Regular security checks and ad hoc inspection if necessary
Report incidents (if any) at the MRM
Periodic review of effectiveness of the action plan
Description GMaP ISO
Assess the hazard to products posed by potential acts of sabotage, vandalism, or terrorism and implement proportional protective measures, such as the following:- The compound is well protected.- Access to the workplace is controlled by security guards at entrances.- Security patrols and closed-circuit television systems are active.
Potentially sensitive areas within the establishment should be identified, mapped, and subjected to access controls.
Where feasible, access should be physically restricted by use of locks, electronic cardkeys, or alternative systems.
I.C.4.1 18.1
18.2
Points in the process that are vulnerable to intentional product tampering or intentional contamination have been identified and subjected to additional access controls.
I.C.4.2
Control measures are in place to address what to do with products if prohibited access has taken place and the product may have been tampered with or intentionally contaminated.
I.C.4.3
Records requiredThreat assessment critical control pointHygiene and personal property control forms to be completed by contractors and visitors before they enter the premises (see also: 1.10 Personal Hygiene and Employee Facilities)Security personnel duty roster
21
1.16. FOOD FRAUDM
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Establish the food fraud team
Map and verify the food supply chain
Conduct a vulnerability assessment and critical control point (VACCP) analysis
Implementation and verification
Determine VACCP points and mitigation actions
Documented information
1.4. WASTE MANAGEMENT
Training of food fraud team and related staff
Mitigation plan implementation, monitoring, and testing
Root cause analysis and corrective action implementation
Periodic review and updating
Description GMaP ISO
List of members of the food fraud teamSupply chain flow chartRecords of vulnerability assessmentRecords of risk assessmentList of VACCP pointsFood fraud mitigation planFood fraud review scheduleReview food fraud programRecord corrective actionVerification and testing records
4.1
Records requiredVulnerability assessmentRisk assessmentVerification and testing recordsRecords of corrective actions
23
2.1 CONTEXT OF THE ORGANIZATIONM
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pd
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Req
uir
emen
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Identify internal and external context and issues
Organizational context analysis tools
Activity planning
Monitoring and review
Trends and CAPA
Report at the MRM
Periodic review of the context
Monitoring, recording, reviewing, and updating
Training of the team
GMaPClause
no....
ISO 22000Clause
no.4.1
Context of the organizational system requirements
- A process for understanding key issues- Internal and external issues- Strengths, weaknesses, opportunities, and threats (SWOT) analysis- Relevancy to those that affect the intended results of the FSMS- Strategy and action plan to address issues- Monitoring and review of context- Update information- Record of the MRM
24
2.2. NEEDS AND EXPECTATIONS OF INTERESTED PARTIESM
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Identify relevant interested parties
Determine needs and expectations
Rank interested parties in terms of power and interest
Set objectives and priorities
Monitoring and review
Trends and record of CAPA
Report at the MRM
Periodic review of interested parties
Monitoring, recording, reviewing, and updating
Training of all staff
GMaPClause
no....
ISO 22000Clause
no.4.2
Needs and expectations of interested parties: system requirements
- Roles and responsibilities- Relevant interested party register- Ranking criteria; results of ranking; record- Objectives and priorities in addressing requirements- Regular review, monitoring, and updated information- Records of the MRM
25
2.3. SCOPE OF THE FOOD SAFETY MANAGEMENT SYSTEMM
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Determine the boundaries and applicability of the FSMS
Specify the products and services, processes, and production sites
Consider the context of the organization
Maintain documented information
Updated SWOT and interested party analysis
Strategic directions of the organization
Report at the MRM
Periodic review of the scope of the FSMS
Boundaries and applicability of the FSMS
Training of management and the food safety team
GMaPClause
no....
ISO 22000Clause
no.4.3
Scope of the FSMS requirements
- Boundaries and applicability of the FSMS- Processes, products, services, and production sites- Results of the SWOT and interested party analysis- Evaluation results on the influences of activities, processes, products, and services on food safety of end products- Documented information- Scheduled review
26
2.4. THE FOOD SAFETY MANAGEMENT SYSTEMM
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& U
pd
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Determination of FSMS processes
Specify the products and services, processes, and production sites
Monitoring and evaluation of FSMS processes
Define methods and criteria for each process
Improving FSMS processes
Retain documented Information
Process monitoring and implementation of key performance indicators
Implementation of corrective action
Periodic review and updating
Training of all process owners
GMaPClause
no. I.A.10.1
ISO 22000Clause
no.4.4
FSMS process: system requirements
- Roles and responsibilities for each process- Processes and process Interactions- Process descriptions- Records of process monitoring- Key performance indicators
27
2.5. THE FOOD SAFETY POLICYM
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& U
pd
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Define food safety policy
Approval and communication of the food safety policy
Monitor and review of the food safety policy
Understanding the food safety policy
Update the food safety policy
Maintain documented information
Review and communication of policy
Periodic testing of policy understanding
Periodic review and update of the policy
Training of all staff
GMaPClause
no. ...
ISO 22000Clause
no.5.2
Food safety policy: system requirements
- Roles and responsibilities- Food safety policy- Communication plan and attendance- Records of policy communications- Records on policy understanding- Records of reviews and updates- Documented information
28
2.6. ORGANIZATIONAL ROLE, RESPONSIBILITY, AND AUTHORITYM
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tain
& U
pd
ate
Define roles, responsibilities, and authority
Approval and communication of responsibilities and authority
Report on the performance of the FSMS
Establishing the food safety team and the team leader
Define the responsibility and authority to initiate and document actions
Responsibility to report on problems in the FSMS to relevant individuals ISO 22000
FSMS performance reporting and review
Report problems and initiate document action
Monitor, review, and update responsibilities and authority
Training of human resource staff, the food safety team, and the team leader
GMaPClause
no. ...
ISO 22000Clause
no.5.3
Organizational role, responsibility, and authority: system requirements
- Job description- Organigram/ Organization Chart- Team and team leader assignment letter- Report on FSMS performance- Letter of assignment and minutes to initiate and document action- Report on problems in the FSMS to relevant individuals
29
2.7. RISKS AND OPPORTUNITIESM
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& U
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Identification of risks and opportunities
Evaluation and prioritization of risks and opportunities
Monitor, review, and update
Define actions to address risks and opportunities
Documented information
Performance monitoring on risks and opportunities Management implementation
Corrective actions
Regular review and update
Training of management, team, and department managers
GMaPClause
no. ...
ISO 22000Clause
no.6.1
Risks and opportunities: system requirements
- List of risks and opportunities- List of risks related to FSMS processes- Risk assessment process and methodology- Risks and opportunities mitigation action plan- Monitoring and review: records
30
2.8. FOOD SAFETY OBJECTIVESM
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ate
Establish food safety objectives which are consistent with food safety policy
Establish specific, measurable, attainable (or achievable), realistic, and time-bound (SMART) food safety objectives that reflect food safety requirements
Planning to achieve food safety objectives
Objectives should be defined at relevant functions and levels
Monitor, review, and update
Documented information
Performance monitoring and evaluation of food safety objectives and implementation
Corrective action implementation
Periodic review and update
Training managers
GMaPClause
no. ...
ISO 22000Clause
no.6.2
Food safety objectives: system requirements
- Lists of FSMS objectives at relevant functions and levels- Links with food safety policy- Organizational and departmental baseline data- Action plan for achieving food safety objectives- Results of performance monitoring and evaluation
31
2.9. CHANGE MANAGEMENTM
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& U
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Establish the team
Determine any changes in the FSMS (processes, procedures, inputs,resources, suppliers, personnel, output, interested parties, and so on)
Planning the changes (consider the effects on the integrity of the FSMS,the allocation of resources, the staff, and so on)
Determine the purpose and consequences of each change (risk and opportunity assessment of the changes)
Communicate, implement, and monitor the changes
Documented information
Risk and opportunity assessment of changes
Monitoring the implementations of the changes and corrective actions
Periodic review and update
Training managers
GMaPClause
no. ...
ISO 22000Clause
no.6.3
Change management: system requirements
- Changes generated by different sources- The need for the changes- Records on the risk and opportunity assessment of the proposed changes- Information for relevant interested parties- The results of implementation and monitoring- Maintain and retain documented information
32
Competence: system requirements
- A process to carry out competency assessment- Competence requirements for each job- Organigram- List of competence gaps- A multidisciplinary food safety team- Lists of actions to fill existing competency gaps- A list of all employees- Training needs assessments- Competency matrix, including training- Results of implementation and effectiveness evaluations- Competency evaluation records- Maintain and retain documented information
2.10. COMPETENCEM
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pd
ate
Establish a process for assessing existing staff competencies and determine gaps in competence
Determine the need for action
Implement actions
Define actions to address the competence gaps, including any needs in training
Evaluate the effectiveness of the actions taken
Documented information
Implementation of a competency assessment process
Monitoring the implementations and evaluation of actions
Periodic review and upgrading
Training of human resource and process managers
GMaPClause
no. B.A.9I.A.9
ISO 22000Clause
no.7.2
33
Infrastructure: system requirements
- Lists of necessary infrastructure- Resources plan and budget- Suitable infrastructure for FSMS and process operations- Preventive maintenance schedule- Maintenance procedures- Maintenance records- Maintenance orders- Trend analysis- Results of infrastructure monitoring and evaluation- Maintain and retain documented information
See also 1.2. Layout of premises and the workspace
2.11. INFRASTRUCTUREM
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tain
& U
pd
ate
Identify the infrastructure necessary for the FSMS and for process operations and control
Evaluate the adequacy of the necessary infrastructure
Maintain infrastructure to ensure continuing suitability
Provide the necessary infrastructure
Documented information
Implementation of preventive maintenance schedules and procedures
Monitoring and corrective actions
Periodic review and upgrading
Training a maintenance team
GMaPClause
no. ...
ISO 22000Clause
no.7.1.3
34
2.12. WORK ENVIRONMENTM
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& U
pd
ate
Determine the resources needed for the establishment, management, and maintenance of the work environment necessary for the FSMS
Provide and manage the work environment necessary for the FSMS and for product conformity
Documented information
Monitor and maintain the work environment needed
Managing the work environment
Monitoring and maintenance
Periodic review and updating
Training all staff and the occupational health and safety team
GMaPClause
no. ...
ISO 22000Clause
no.7.1.4
Work environment: system requirements
- A budget plan for the work environment- Lists of human and physical factors in the work environment- Regulations- Records of personal protective equipment provision and use- Results of monitoring and maintenance- Records on work environment inspections- Maintain and retain documented information
See also 1.2. Layout of premises and the workspace and 1.10. Personal hygiene and employee facilities
35
2.13. COMMUNICATIONM
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Identify internal and external communications relevant to the FSMS
Define a communication plan on what, who, when, and how to communicate
Monitor and control internal and external communications
Communicate the plan and make the communication process transparent
Documented information
Communication plan implementation
Monitoring and control of communications
Periodic review and updating
Training managers
GMaPClause
no. ...
ISO 22000Clause
no.7.4
Communication: system requirements
- Communication process and procedures- Communication plan- Records of communications with relevant interested parties- Results of monitoring and control- Documented information
36
2.14. DOCUMENTED INFORMATIONM
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& U
pd
ate
Identify the documented information required by the FSMS standard, the organization, and statutory and regulatory requirements
Define methods for creating, identifying, reviewing, indexing, retrieving, and updating FSMS documented information
Monitor documented information
Control documented information
Maintain and retain documented Information
Consistent implementation of procedures for the creation, updating, and control of documented information
Monitoring the process and corrective actions
Periodic review and updating
Training all staff
GMaPClause
no. I.A.10.1I.A.10.2
ISO 22000Clause
no.7.5
Documented information: system requirements
- Lists of documented information- Creation and updating of procedures- Master lists of FSMS documents- Distribution lists- Results of monitoring and evaluation- Records on the management and retrieval of FSMS records- Documented information
37
Traceability: system requirements
- Identification and traceability process and procedures- Unique identification codes- Records of raw materials in receiving, the production process, testing, monitoring, and dispatch- Records of product status- Schedule for testing and verification- Records of traceability testing and verification- Results of monitoring and control- Documented information
See also 1.12. Product withdrawal and recall
2.15. TRACEABILITYM
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pd
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Define a process and procedures for traceability
Implement an identification and traceability system
Retain documented information
Monitor and test the traceability system
Periodic testing and verification
Process monitoring and control
Periodic review and updating
Training supply chain staff
GMaPClause
no. I.A.2
ISO 22000Clause
no.8.3
38
2.16. EMERGENCY PREPAREDNESS AND RESPONSEM
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pd
ate
Establish procedures to identify and respond to emergency situations and incidents
Identify potential emergency situations and incidents
Monitoring and periodical testing of procedures to respond to emergencies and incidents
Take steps to reduce the consequences of emergency situations and incidents
Documented information
Review and revise emergency preparedness and response procedures
Implementation of emergency preparedness and response plan
Monitoring and periodic testing of procedures and corrective actions
Periodic review and updating
Training all staff
GMaPClause
no. ...
ISO 22000Clause
no.8.4
Emergency preparedness and response: system requirements
- A procedure to respond to emergency situations and incidents which shall also be aligned with Workplace Safety requirements - Lists of potential emergency situations and incidents- Emergency preparedness and response plan- Results and records of monitoring and periodical testing- Documented information
39
2.17. CONTROL OF MONITORING AND MEASUREMENTM
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Identify monitoring and measurement methods and equipment
Establish a calibration and verification plan
Monitor and verify monitoring and measurement methods and equipment
Ensure monitoring and measurement methods and equipment are reliable
Documented information
Implementation of the calibration and verification plan
Monitoring and verification of calibration and verification
Periodic review and updating
Training the quality, production, and maintenance team
GMaPClause
no. I.A.8
ISO 22000Clause
no.8.7
Control of monitoring and measurement: system requirements
- Lists of monitoring and measurement methods and equipment- Calibration and verification plan- Records of calibration and verification- Calibration status of each piece of equipment- Results and records of monitoring and verification- Documented information
40
2.18. NONCONFORMITY AND CORRECTIVE ACTIONSM
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pd
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Identification of nonconformity
Define methods to react to nonconformity
Implement any necessary actions
Evaluate the need for actions to eliminate the causes of nonconformity
Documented information
Review the effectiveness of any corrective actions taken
Root cause analysis and implementation of corrective action
Monitoring and review of the effectiveness of corrective actions
Periodic review and updating
Training all staff
GMaPClause
no. B.A.4 B.A.5
ISO 22000Clause
no.10.1
Nonconformity and corrective action: system requirements
- A procedure for handling nonconformity and corrective actions- Lists of nonconformities- Area for the segregation of nonconformity and quarantine- Records of root cause analysis and corrective actions- Action plan to eliminate causes of nonconformity- Records on the effectiveness of corrective actions- Documented information
41
2.19. WITHDRAWAL AND RECALLM
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& U
pd
ate
Identification of potential withdrawals and recalls
Convene the withdrawal and recall team
Identify the batches affected, isolate stocks, and identify where the product has been distributed
Evaluate the need for product withdrawal and quarantine
Review and verify the effectiveness of a withdrawal or recall
Documented information
Notify relevant bodies and conduct product withdrawal or recall
Root cause analysis and implementation of corrective actions
Monitoring and review of the effectiveness of withdrawal and recall
Periodic review and updating
Training the sales and recall team
GMaPClause
no. B.A.3I.A.3
ISO 22000Clause
no.8.9
Withdrawal and recall: system requirements
- A procedure for withdrawals and recalls- List of the withdrawal and recall team- Minutes on decisions and actions- Distribution route and contact lists of direct customers- Records on quarantined products- Records of root cause analysis and corrective actions- Notification letter to authorities and customers- Press release and media communication- Templates of withdrawal and recall records- Documented information
See also 1.12. Product withdrawal and recall
42
2.20. PERFORMANCE EVALUATION M
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& U
pd
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Define process monitoring, measurement, analysis, and evaluation
Evaluate the performance and effectiveness of the FSMS
Review the FSMS
Analysis and evaluation of data and information
Documented information
Monitoring, measurement, analysis, and evaluation
Root cause analysis and implementation of corrective actions
Periodic review and updating
Training the management and evaluation team
GMaPClause
no. ...
ISO 22000Clause
no.
9.19.29.3
Performance evaluation: system requirements
- Monitoring and measurement plan- Records of monitoring and measurement- Internal audit (related FSMS Element 2.21. Internal Audit)- Results of data and information analysis- MRM schedule (related FSMS Element 2.22. Management Review Meeting)- FSMS review minutes- Records on corrective actions
43
2.21. INTERNAL AUDITM
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& U
pd
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Form the internal audit team
Conduct IFC internal audit training among the team
Develop an internal audit plan
Implement an internal audit program
Ensure the CAPA are effective and then close the audit
Report incidents (if any) at the MRM
Periodically review the effectiveness of the internal audits
Conduct internal audit according to the defined schedule
Communicate the internal plan to the organization
GMaPClause
no. ...
ISO 22000Clause
no.9.2
Internal audit: system requirements
- Internal audit team- Internal audit master plan- Internal audit reports- CAPA and audit closures
44
2.22. MANAGEMENT REVIEW MEETINGM
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tain
& U
pd
ate
Assess current communications in the organization
Plan the MRM
Implement the MRM
Record decisions and action plans
Follow up on CAPA closures and continuous improvement
Periodic review of the effectiveness of the MRM
Conduct the MRM according to the schedule
Communicate the MRM plan to the organization
GMaPClause
no. ...
ISO 22000Clause
no.9.3
MRM: system requirements
- List the invitees- MRM presentation format- Meeting minutes- Action plan, CAPA, and closure- Evaluation whether the FSMS conforms to the food safety policy and meets the objectives of the FSMS
46
3.1. DEVELOPMENT OF THE HACCP PLAN M
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& U
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ate
Assemble the food safety–HACCP team
Describe food and the distribution of foodDescribe the intended use and the consumers of the food
Define the scope of the HACCP (Worksheet 1) Describe the product and ingredients (Worksheet 2) Analyze the hazards at each process step (Worksheet 4) Use a decision tree and select operational PRPs (OPRPs) and critical control points (CCPs) (Worksheet 5) Validate control measures (Worksheet 6)
Develop a flow diagram that describes the process Verify the flow diagram (Worksheet 3)
Finalize the HACCP plan, including identified control measures, critical limits, corrective actions, and responsibilities (Worksheet 7)
Verify the HACCP plan (Worksheet 8)
Corrections and corrective actions, the if/when parameter is out of critical control limits
Follow up with CAPA to close incidents
Periodic review of HACCP plan effectiveness
Maintain records on OPRPs and CCPs (ongoing)
Overview of HACCP training for all staff
Train OPRP and CCP operators on control and actions
Refer to 3.2 for system and training requirements
47
3.2. HACCP SYSTEM REQUIREMENTSSy
stem
& T
rain
ing
Req
uir
emen
ts
Description GMaP ISO
Business is in compliance with regulatory and customer requirements related to processes and products
B.C.1
The HACCP plan is in place, as follows:Food safety hazards are to be controlled at the OPRP and CCPCritical limits are set at the CCP or the action criteria for the OPRPMonitoring proceduresCorrection to be made if critical limits or action criteria are not metResponsibilities and authorities
I.C.3 8.5.4.18.5.4.2
The HACCP monitoring plan is in place, as follows:Measurements or observations that provide results within an adequate time frameMonitoring methods or monitoring devices are usedApplicable calibration methods or, for the OPRPs, equivalent methods for the verification of reliable measurements or observationsMonitoring frequencyMonitoring resultsResponsibility and authority for monitoringResponsibility and authority for the evaluation of monitoring results
8.5.4.3
Action plan to ensure the following:Potentially unsafe products are not releasedThe cause of nonconformities is identifiedThe parameters controlled at the CCP or by the OPRP are within the critical limits or action criteriaRecurrence is prevented
8.5.4.4
Updates are undertaken in the HACCP plan if/when changes occur in the following:Characteristics of raw materials, ingredients, and product contact materialsCharacteristics of end productsIntended useFlow diagrams and descriptions of processes and the process environment
8.6
Controls and calibration of monitoring and measurement equipment are in place 8.7
A verification plan is in place 8.8
Training requirements• IFC Food Safety Handbook, HACCP training for food safety, HACCP team• CCP and OPRP training for relevant staff who deal with CCPs or OPRPs• Training in the HACCP plan for all staff• Refresher training at least annually
Records requiredLetter of appointment for the food safety–HACCP teamProduct descriptions (including raw materials, packaging materials, finished products, and storage and distribution conditions), intended product use, target consumersProcess flow diagram and verification recordHazard analysisHACCP plan and verification recordsOPRP and CCP monitoring recordsCorrective action recordsCalibration records for testing and measuring devices at the CCPsRelevant training records
49
ANNEX 1: TIPS FOR VIRTUAL TRAINING AND COACHING
Assess, train, coach, and reassess is the model IFC food safety team uses in delivering advisory services. Specialists and consultants should ensure that they have reviewed the assessment thoroughly so that attention is tailored during training and coaching.Because the COVID-19 pandemic has imposed travel restrictions, the modality of service delivery has changed and become mostly virtual or a mixture of virtual and face-to-face training and coaching. While virtual delivery saves on trips to the food business, specialists and consultants obviously need to spend additional effort and energy on thorough preparation, delivery, and summary analysis. They also need to be more flexible and adaptable in managing the challenges compared with face-to-face training and coaching.
Virtual trainingTips that the consultant can use in virtual training are as follows:• Do not create virtual relationships; create real relationships virtually (reference: The Modern Virtual Classroom Experience: Facilitating the Experience: Developing Competence and Creating Engagement, link to Amazon provided below)• Pay attention to these five competencies of a trainer-facilitator—virtual classroom fluency, digital literacy, cultural intelligence, time management, and adult learning principles.• Manage risks—technology risks and people problems or behavioral risks (attached: disaster prevention tips and an infographic).• In virtual training, develop whenever possible a checklist for the facilitator and the producer and define roles and responsibilities, including details on pre-session, online session, and post-session activities.• Maintain interactive training as much as possible.• Do not forget to undertake icebreaker, stretching, or Yoga activities in the virtual classes.
https://tinyurl.com/xjspse8
Virtual coachingThis is the point at which specialists and consultants switch roles from trainer to coach. Clearly communicate with the client team that the specialists or consultants will now take on the role of coach and will perform the following:• Prepare agendas for coaching sessions in advance and in consultation with the coachees.• Arrive with the materials and mindset to deliver professional coaching services.• Attend all coaching sessions as planned.• Inform the developer at least 48 hours in advance if they cannot attend a session.
• Use continuous improvement tools to support the development of the developer. • Identify additional advisors or services the developer may need.• Be available by e-mail and phone as needed.• Review the assessment results and report on them prior to the first session.• Provide guidance as appropriate to address questions and concerns.• Track sessions and progress.• [Add as desired]
And the coachee will undertake the following:• Commit to seeking to understand and apply the continuous improvement tools.• Commit to and follow through on strategic action plan next steps.• Understand that there are no guaranteed results, even if the work is done.• Provide input on coaching session agendas.• Be prepared for, schedule, and ensure that the appropriate people are present, attend, and actively participate in all coaching sessions.• Create, update, and maintain the strategic action plan.• Inform the coach of any changes that may impact the progress toward the goals.• Inform the coach at least 48 hours in advance if they cannot participate in the session.• [Add as desired]
How to prepare technically for virtual coachingIn coaching virtually, specialists and consultants need to consider the following:• Choose a platform where the audience can see face-to-face, access the session through various audio options (phone, computer), and share screens and documents.• Create a shared space (SP, OneDrive, Dropbox) where documents may be shared.• Plan to capture the discussions and action plan. Use meeting memos or a shared document to record this material, update between sessions, and follow up during the next section.• Check often throughout the call that the connection is good and that the other person is able to view the shared screen.• Use various features available on the platform to engage the participants.• Log into the call early.
How to prepare a conducive learning environmentVirtual learning requires more effort by coaches, too. Consultants are also encouraged to prepare the learning environment as much as possible.
50
ANNEX 1: TIPS FOR VIRTUAL TRAINING AND COACHING
• A coaching session that is too long will exhaust the coaches and risk losing the focus of the sessions.The recommended duration and frequency are as follows:• Twice a week for one hour a day or once a week for two hours a day• If the session lasts for two consecutive hours, add a five-minute break after one hour• As often and as practical as possible, allow fewer people to connect individually through their own devices to lower network connection issues and to create a learning environment together; for instance, use a conference room where the majority can gather together.• Include relevant personnel, depending on the subject of the coaching session (such as waste management, purchasing, and so on)• Use a platform that is user friendly, that is, it takes into account the limitations of some groups of people, for instance, people with special needs.
How to prepare the coacheesBefore starting the delivery of the coaching:• Spend time assessing the knowledge of participants on food safety.• Ensure the coach knows which type of participants will be present and adapt the delivery form accordingly (for example, talking speed, the mandatory use of video by the trainer in the case of people with special needs.
How to plan a coaching sessionThe coaches are encouraged to have a planning session with the coachee before coaching begin to nail the following things down:• What are the goals of the coaching sessions?• When and how frequently should the sessions be held?• Where should the sessions be held?• What is the measure of success?• Who should attend?• Has everyone taken the required courses?
How to conduct a coaching sessionBefore sessions:• Ensure that the meeting logistics are clearly agreed and communicated.• Prepare by reviewing documentation and listing any questions.During sessions:• Make introductions• Check in on the developer’s frame of mind using key coaching questions—attitude, challenges, and success• Clarify the objectives of the coaching session• Review the outcomes and action items of the previous session• Address the meeting content specific to the session
• Set action items for the next session• Wrap up and assess the sessionAfter sessions:• Share the documentation captured during the session
How to engage the participants during coachingStart each session by asking a few check-in questions to gauge the mood and mindset of participants. Examples of check-in questions include the following:• How did the last session affect you and your work?• What is challenging you today?• What is the one accomplishment you want to achieve through today’s session?Ask questions such as the following:• What progress are you making on your action items?• What challenges have you faced?• Do we need to revise the plan or adjust how we view deadlines?• What lessons have you learned in working on your action items?• What continuous improvement tools did you use?Use features available on the platform:• The chat function to comment or raise question without disturbing the flow of discussion• Use the hand raising function to get the coach’s attention and ask or answer a question or make a comment• Create a poll or a multiple choice exercise for decision-making• Use whiteboard or annotation to share comments and opinions, and so on
In addition to the above, the four Ps help them identify what participants want to achieve and why.• Position: What position (or goal) do you want to achieve?• Problem: What problems or challenges are you encountering?• Possibilities: What are the possible solutions to this problem?• Plan: How do you plan to implement the chosen solution?Thinking about the problem in this order helps avoid incorrect assumptions and incorrect conclusions. It also helps the developer learn a structured problem-solving approach.
Remember the following:• Be the coach. The task is to coach and mentor, not to do the work.• Celebrate success. Take time to congratulate each other.• Help identify additional resources or training needs. You do not need to be the only resource or trainer.• Above all, help leaders understand that proficiency building is a continual process, not a one-time
51
ANNEX 2: SCHEDULING AND PROJECT TRACKING
ObjectivesThe IFC food safety team has prepared a tracker for planning and keeping track of the project. The objective of tracking food safety projects is to understand the progression of projects across the board as well as to provide support for projects that are slow in achieving progress.
How to use this project tracker• This tool is to be used as a guideline for scheduling and tracking the progress of advisory service delivery.• It is recommended that a mutually agreeable implementation plan be prepared with the client food safety team—set a clear timeline, identify the milestones in major activities, and update the schedule regularly.• In case of any unforeseen circumstances that might cause a delay in the project or if there are any changes in ownership of activities, the tracker should be updated.• Most of the PRPs, HACCP, and FSMS elements can be scheduled in parallel, but successful implementation is based not only on the
consultant, but also on the client’s ambition for certifi cation, the resources available, and the capacity of the assigned personnel.• In preparing the schedule, the modality of training and coaching (face-to-face, virtual, or a combination) should also be considered so that an adequate time can be allocated for activities.• The Excel fi le includes two worksheets. The fi rst is a project tracker, and the second is list of the documented information required for GMaP, ISO22000-2018, and ISO 22002-TS.• The tracker is prepared in the Excel format with the following columns. However, the specialist or consultant may make necessary adjustments. - The activities required to meet the GFSI checklist - The respective GFSI clause - Task leads: the consultant and food safety team lead or designated client team member - Target deadline - (Revised deadline) - Status - Notes• Project tracker
52
Ph
ase
Act
ivit
yG
FSI
cla
use
Task
Le
ad
IFC
Task
Le
ad
C
lien
tD
ead
lines
Rev
ised
d
ead
lines
(i
f a
ny)
Sta
tus
No
tes
1,0
Foo
d S
afe
ty In
itia
l Ass
essm
ent
1,1
Con
duct
bas
elin
e
asse
ssm
ent
1,2
Prov
ide
Food
Saf
ety
A
sses
smen
t re
port
wit
h ac
tion
pla
n an
d su
mm
ary
1,3R
evie
w re
sult
s of
bas
elin
e as
sess
men
t w
ith
Seni
or
Man
agem
ent
2,0
IFC
Fo
od
Sa
fety
Co
urs
es
2,1
Prov
ide
IFC
Foo
d Sa
fety
Fo
unda
tion
cou
rse
2,2
Prov
ide
IFC
Foo
d Sa
fety
H
andb
ook
Trai
ning
2,3
Prov
ide
trai
ning
for i
nter
nal
audi
tors
3,0
Dev
elo
p a
nd
imp
lem
ent
pre
req
uis
ite
pro
gra
ms
(PR
P)
ag
ain
st IS
O/T
S 22
00
2-1
(cla
use
s 4-
18);
ISO
220
00
cla
use
8.2
an
d F
SSC
ad
dit
ion
al r
eq.
Dea
dlin
e fo
r D
ocu
men
t D
evel
op
men
t &
Im
ple
men
tati
on
Dea
dlin
e fo
r In
fra
stru
ctu
re
Up
gra
des
C
om
ple
tio
n
3,1
Con
stru
ctio
n an
d la
yout
of
bui
ldin
gs/ P
RP4
; C
laus
e 8.
2.4.
a
B.B
.2
3,2
Layo
ut o
f pre
mis
es a
nd
wor
kspa
ces;
zon
ing/
PR
P 5;
C
laus
e 8.
2.4.
b
B.B
.2
3,3
Uti
litie
s - a
ir, w
ater
, ene
r-gy
; ot
her u
tilit
ies/
PR
P6;
Cla
use
8.2.
4.c
B.B
.6
3,4
Was
te d
ispo
sal;
sew
age
disp
osal
and
sup
port
ive
serv
ices
/ PR
P7
B.B
.8
3,5
Equi
pmen
t su
itab
ility
, cl
eani
ng a
nd m
aint
enan
ce/
PRP8
; Cla
use
8.2.
4.e
B.A
.8;
I.A.8
; I.B
.10
PR
OJE
CT
TR
AC
KER
IFC
AD
VIS
OR
Y T
IMEL
INE
FOR
FO
OD
SA
FET
Y IM
PLE
MEN
TAT
ION
Up
da
teO
= O
uts
tan
din
g /
En
ret
ard
C =
Co
mp
lete
d /
Ach
eve
53
Ph
ase
Act
ivit
yG
FSI
cla
use
Task
Le
ad
IFC
Task
Le
ad
C
lien
tD
ead
lines
Rev
ised
d
ead
lines
(i
f a
ny)
Sta
tus
No
tes
Dea
dlin
e fo
r D
ocu
men
t
Dev
elo
pm
ent
&
Imp
lem
enta
tio
n
Dea
dlin
e fo
r In
fra
stru
ctu
re
Up
gra
des
C
om
ple
tio
n
3,6
Man
agem
ent
of p
urch
ased
m
ater
ials
(su
pplie
r ap
prov
al; r
ecep
tion
; sp
ecifi
cati
ons)
/ PR
P9; 8
.2.4
f a
nd g
I.A.13
; I.A
.14;
B.A
.1
3,7
Mea
sure
s fo
r pre
vent
ion
of c
ross
con
tam
inat
ion/
PR
P10
; Cla
use
8.2.
4.h
(FSS
C
see
belo
w-A
llerg
en)
B.B
.4;
B.C
.2;
3,8
Cle
anin
g an
d Sa
niti
zing
(d
isin
fect
ion)
/ PR
P11 ;
C
laus
e 8.
2.4.
i
B.B
.3
3,9
Pest
Con
trol
/ PR
P12;
Cla
use
8.2.
4.d
B.B
.5
3,10
Pers
onne
l hyg
iene
and
em
ploy
ee fa
cilit
ies/
PR
P13;
C
laus
e 8.
2.4.
j
B.B
.1;
B.B
.7
3,11
Rew
ork/
PR
P14
3,12
Prod
uct
reca
ll pr
oced
ures
/ PR
P15
3,13
War
ehou
sing
/ PR
P16;
C
laus
e 8.
2.4.
gB
.B.9
; I.B
.9
3,14
Prod
uct
info
rmat
ion
& c
on-
sum
er a
war
enes
s/ P
RP1
7;
Cla
use
8.2.
4.k
3,15
Food
def
ence
, bio
vigi
lanc
e an
d bi
oter
rori
sm/ P
RP1
8.
FSSC
2.5
.3 F
ood
defe
nce
plan
(thr
eat
asse
ssm
ent,
Pl
an)
I.C.4
3,16
Veri
ficat
ion
of P
RPs
(ISO
22
00
0 re
quir
emen
ts -
Cla
use
8.2.
4 an
d 8.
8)
3,17
Upd
atin
g th
e in
form
atio
n sp
ecify
ing
the
PRPs
/ (IS
O
220
00
; Cla
use
8.6)
PR
OJE
CT
TR
AC
KER
IFC
AD
VIS
OR
Y T
IMEL
INE
FOR
FO
OD
SA
FET
Y IM
PLE
MEN
TAT
ION
Up
da
teO
= O
uts
tan
din
g /
En
ret
ard
C =
Co
mp
lete
d /
Ach
eve
54
Ph
ase
Act
ivit
yG
FSI
cla
use
Task
Le
ad
IFC
Task
Le
ad
C
lien
tD
ead
lines
Rev
ised
d
ead
lines
(i
f a
ny)
Sta
tus
No
tes
4,0
Dev
elop
and
impl
emen
t FS
MS
ISO
220
00
: 20
18
4,1
Con
text
of t
he o
rgan
izat
ion
( FSM
S sc
ope,
inte
rest
ed
part
ies)
/ C
laus
e 4.
1- 4
.4
4,2
Lead
ersh
ip a
nd c
omm
it-
men
t/ C
laus
e 5.
1B
.A.6
: I.A
.6
4,3
Food
Saf
ety
polic
y an
d it
’s co
mm
unic
atio
n/ C
laus
e 5.
2
4,4
Org
aniz
atio
nal r
oles
, re-
spon
sibi
litie
s an
d au
thor
i-ti
es/ C
laus
e 5.
3
4,5
Plan
ning
, Ris
k an
d O
ppor
-tu
niti
es, P
lann
ing
chan
ges/
C
laus
e 6.
1 and
6.3
4,6
FSM
S O
bjec
tive
/ Cla
use
6.2
4,7
Supp
ort;
Res
ourc
es/ C
laus
e 7.1
( 7.1
.1-7.1
.6)
4,8
Com
pete
nce
and
Aw
are-
ness
/ C
laus
es 7.
2- 7.
3B
.A.9
; I.A
.9
4,9
Com
mun
icat
ion
(Int
erna
l, Ex
tern
al)/
Cla
use
7.4
4,10
Doc
umen
ted
Info
rmat
ion/
C
laus
e 7.
5B
.A.7.
; I.A
.7;
I.A.10
4,11
Ope
rati
on;
Plan
ning
and
co
ntro
l/ C
laus
e 8.
1
4,12
Prer
equi
site
pro
gram
mes
/ C
laus
e 8.
2; S
ee p
hase
3.0
ab
ove
PR
OJE
CT
TR
AC
KER
IFC
AD
VIS
OR
Y T
IMEL
INE
FOR
FO
OD
SA
FET
Y IM
PLE
MEN
TAT
ION
Up
da
teO
= O
uts
tan
din
g /
En
ret
ard
C =
Co
mp
lete
d /
Ach
eve
55
Ph
ase
Act
ivit
yG
FSI
cla
use
Task
Le
ad
IFC
Task
Le
ad
C
lien
tD
ead
lines
Rev
ised
d
ead
lines
(i
f a
ny)
Sta
tus
No
tes
4,13
Trac
eabi
lity
syst
em/
Cla
use
8.3
B.A
.2;
I.A.2
4,14
Emer
genc
y pr
epar
edne
ss
and
resp
onse
/ Cla
use
8.4
B.A
.3;
I.A.3
:
4,15
Con
trol
of M
onit
orin
g an
d M
easu
ring
/ Cla
use
8.7;
See
ab
ove
phas
e 3.
5
B.A
.8;
I.A.8
4,16
Con
trol
of p
rodu
ct a
nd
proc
ess
nonc
onfo
rmit
ies/
C
laus
e 8.
9
B.A
.4;
I.A.12
4,17
Cor
rect
ion
and
corr
ecti
ve
Act
ions
; com
plai
nts
han-
dlin
g/ c
laus
e 8.
9.2-
8.9.
3
B.A
.5;
I.A.11
4,18
Han
dlin
g of
pot
enti
ally
un-
safe
pro
duct
s/ C
laus
e 8.
9.4
4,19
Wit
hdra
wal
/rec
all/
Cla
use
8.9.
5; s
ee a
bove
pha
se 3
.12
( PR
P 15
)
4,20
Perf
orm
ance
Eva
luat
ion
(Mon
itor
ing,
mea
suri
ng,
anal
ysis
and
eva
luat
ion)
/ C
laus
e 9.
1
4,21
Inte
rnal
aud
its/
Cla
use
9.2
4,22
Man
agem
ent
Rev
iew
/ 9.
3
4,23
Impr
ovem
ent;
Con
tinu
al/
Cla
use
10.2
4,24
Impr
ovem
ent;
Non
-con
-fo
rmit
y an
d co
rrec
tive
ac
tion
/ Cla
use
10.1
4,25
Upd
ate
of t
he F
SMS/
Cla
use
10.3
PR
OJE
CT
TR
AC
KER
IFC
AD
VIS
OR
Y T
IMEL
INE
FOR
FO
OD
SA
FET
Y IM
PLE
MEN
TAT
ION
Up
da
teO
= O
uts
tan
din
g /
En
ret
ard
C =
Co
mp
lete
d /
Ach
eve
56
Ph
ase
Act
ivit
yG
FSI
cla
use
Task
Le
ad
IFC
Task
Le
ad
C
lien
tD
ead
lines
Rev
ised
d
ead
lines
(i
f a
ny)
Sta
tus
No
tes
5,0
HA
ZAR
D C
on
tro
l; IS
O 2
200
0 C
lau
se 8
.5; C
lau
se 8
.6; C
lau
se 8
.8
5,1
Prel
imin
ary
Step
s to
ena
ble
haza
rd a
naly
sis/
Cla
use
8.5.
1
GFS
I B
.C.1
&
I.C.3
5,2
Cha
ract
eris
tics
of r
aw
mat
eria
ls, i
ngre
dien
ts,
cont
act
mat
eria
ls a
nd e
nd
prod
uct;
Int
ende
d U
se/
Cla
use
8.5.
1.2;
Cla
use
8.5.
1.3;
Cla
use
8.5.
1.4
5,3
Prod
ucti
on p
roce
sses
flo
w-c
hart
s an
d on
-sit
e ve
rific
atio
n/ C
laus
e 8.
5.1.5
.1;
Cla
use
8.5.
1.5.2
5,4
Des
crip
tion
of p
roce
ss
and
proc
ess
envi
ronm
ent/
C
laus
e 8.
5.1.5
.3
5,5
Haz
ard
anal
ysis
; H
azar
d id
enti
ficat
ion
and
dete
rmin
atio
n of
ac
cept
able
leve
l/ C
laus
e 8.
5.2;
Cla
use
8.5.
2.1;
Cla
use
8.5.
2.2
5,6
Haz
ard
asse
ssm
ent/
C
laus
e 8.
5.2.
3
5,7
Sele
ctio
n an
d ca
tego
riza
tion
of c
ontr
ol
mea
sure
(s)/
Cla
use
8.5.
2.4
5,8
Valid
atio
n of
Con
trol
m
easu
res
and
com
bina
tion
of
con
trol
mea
sure
s/ C
laus
e 8.
5.3
5,9
Haz
ard
Con
trol
Pla
n (H
AC
CP/
OPR
P Pl
an);
CC
P an
d O
PRP/
Cla
use
8.5.
4.1
PR
OJE
CT
TR
AC
KER
IFC
AD
VIS
OR
Y T
IMEL
INE
FOR
FO
OD
SA
FET
Y IM
PLE
MEN
TAT
ION
Up
da
teO
= O
uts
tan
din
g /
En
ret
ard
C =
Co
mp
lete
d /
Ach
eve
57
PR
OJE
CT
TR
AC
KER
IFC
AD
VIS
OR
Y T
IMEL
INE
FOR
FO
OD
SA
FET
Y IM
PLE
MEN
TAT
ION
Up
da
teO
= O
uts
tan
din
g /
En
ret
ard
C =
Co
mp
lete
d /
Ach
eve
Ph
ase
Act
ivit
yG
FSI
cla
use
Task
Le
ad
IFC
Task
Le
ad
C
lien
tD
ead
lines
Rev
ised
d
ead
lines
(i
f a
ny)
Sta
tus
No
tes
5,10
Det
erm
inat
ion
of C
riti
cal
Lim
its
for e
ach
CC
P an
d ac
tion
cri
teri
a fo
r OPR
P/
Cla
use
8.5.
4.2
5,11
Mon
itor
ing
syst
em a
t C
CPs
an
d O
PRPs
/ Cla
use
8.5.
4.3
5,12
Act
ion
whe
n cr
itic
al li
mit
s or
act
ion
crit
eria
are
not
m
et/ C
laus
e 8.
5.4.
4.
5,13
Impl
emen
tati
on o
f haz
ard
cont
rol p
lan/
cla
use
8.5.
4.5
5,14
Upd
atin
g th
e in
form
atio
n sp
ecify
ing
the
Haz
ard
con-
trol
pla
n/ C
laus
e 8.
6
5,15
Veri
ficat
ion
of H
azar
d co
ntro
l Pla
n(an
alys
is o
f ver
-ifi
cati
on re
sult
s)/ c
laus
e 8.
8
6,0
Per
form
an
ce E
valu
ati
on
6,1
Con
duct
inte
rnal
aud
it
alon
g w
ith
trai
ned
inte
rnal
au
dito
rs/
6,2
Con
duct
Man
agem
ent
Rev
iew
Mee
ting
/
7,0
Foo
d S
afe
ty F
ina
l Ass
essm
ent
7,1
Prod
uct
labe
lling
/ 2.5
.2 -
se
e ab
ove
phas
e 5.
2
7,2
Food
def
ence
pla
n (t
hrea
t as
sess
men
t, P
lan)
/ 2.5
.3 -
See
abov
e ph
ase
3.15
I.C.4
58
Ph
ase
Act
ivit
yG
FSI
cla
use
Task
Le
ad
IFC
Task
Le
ad
C
lien
tD
ead
lines
Rev
ised
d
ead
lines
(i
f a
ny)
Sta
tus
No
tes
7,0
Foo
d S
afe
ty F
ina
l Ass
essm
ent
7,3
Food
Fra
ud (V
ulne
rabi
lity
asse
ssm
ent,
Foo
d fr
aud
mit
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ion
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7,4
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.5
7,5
Alle
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e 3.
7
B.B
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B.C
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7,6
Envi
ronm
enta
l Mon
itor
ing
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n/ (
cate
gory
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PR
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TR
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IFC
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OR
Y T
IMEL
INE
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FO
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SA
FET
Y IM
PLE
MEN
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ION
Up
da
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= O
uts
tan
din
g /
En
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ard
C =
Co
mp
lete
d /
Ach
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60
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